Eli Lilly Gets FDA Fast-Track Designation for Tirzepatide in Obesity
October 06 2022 - 7:37AM
Dow Jones News
By Colin Kellaher
Eli Lilly & Co. on Thursday said the U.S. Food and Drug
Administration granted fast-track designation to its diabetes drug
tirzepatide for the treatment of adults with obesity or who are
overweight with weight-related comorbidities.
The Indianapolis drugmaker said it plans to initiate a rolling
submission of a new-drug application for the indication this
year.
The FDA's fast-track program is designed to facilitate the
development and expedite the review of treatments for serious or
potentially life-threatening illnesses with high unmet medical
needs.
The FDA in May approved tirzepatide as Mounjaro to improve
blood-sugar control in adults with type 2 diabetes, as an addition
to diet and exercise.
Eli Lilly in April said a Phase 3 study of tirzepatide met its
key endpoints in obese or overweight adults who don't have
diabetes.
The company said its rolling submission, which lets it file
completed sections of the application for review by FDA rather than
wait until all sections are complete, will be based mainly on that
study and a second Phase 3 trial slated to wrap up by the end of
April 2023.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 06, 2022 07:22 ET (11:22 GMT)
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